Introducing LiverMultiScan Introducing LiverMKT155 2.0 ® | UK: (+44) 1865 655325 972 803 5501...
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® MKT155 2.0 ® [email protected] | perspectum.com | US: (+1) 972 803 5501 | UK: (+44) 1865 655325 Introducing LiverMultiScan In a single, non-invasive MRI examination, LiverMultiScan ® characterizes liver tissue by providing three key metrics—PDFF, T2* and cT1. These have been shown to correlate with liver fat 1,2 , iron content 3,4,5 and fibro-inflammation 6,7 respectively. Clinicians will receive reports that include these quantitative metrics to support the diagnosis of liver disorders as inputs forming part of a wider diagnostic process. LiverMultiScan provides measures that can be used to assess a wide variety of liver disorders Diagnosis of liver disease relies on a range of pathological features. Currently available tests do not capture all aspects of disease progression. LiverMultiScan enables the comprehensive assessment of the liver parenchyma. Healthy Liver Fatty Liver Inflamed Liver Fibrotic Liver Cirrhotic Liver ULTRASOUND ELASTOGRAPHY LiverMultiScan provides quantitative metrics for liver tissue characterization Healthy Patient NASH Patient cT1: 950ms Reference range: 633-794ms T2*: 15.3ms Normal range: >12.5ms at 3T PDFF: 22.5% Normal range: <5.6% cT1: 645ms Reference range: 633-794ms T2*: 18.2ms Normal range: >12.5ms at 3T PDFF: 1.8% Normal range: <5.6% cT1 T2* PDFF cT1 T2* PDFF
Transcript of Introducing LiverMultiScan Introducing LiverMKT155 2.0 ® | UK: (+44) 1865 655325 972 803 5501...
®
MKT155 2.0
®
[email protected] | perspectum.com | US: (+1) 972 803 5501 | UK: (+44) 1865 655325
Introducing LiverMultiScan
In a single, non-invasive MRI examination, LiverMultiScan® characterizes liver tissue by providing three key metrics—PDFF, T2* and cT1. These have been shown to correlate with liver fat1,2, iron content3,4,5 and fibro-inflammation6,7 respectively.
Clinicians will receive reports that include these quantitative metrics to support the diagnosis ofliver disorders as inputs forming part of a wider diagnostic process.
LiverMultiScan provides measures that can be used to assess a wide variety of liver disorders
Diagnosis of liver disease relies on a range of pathological features. Currently available tests do not capture all aspects of disease progression. LiverMultiScan enables the comprehensive assessment of the liver parenchyma.
Healthy Liver
Fatty Liver
Inflamed Liver
FibroticLiver
CirrhoticLiver
ULTRASOUNDELASTOGRAPHY
LiverMultiScan provides quantitative metrics for liver tissue characterization
Healthy PatientNASH Patient
cT1: 950msReference range: 633-794ms
T2*: 15.3msNormal range: >12.5ms at 3T
PDFF: 22.5%Normal range: <5.6%
cT1: 645msReference range: 633-794ms
T2*: 18.2msNormal range: >12.5ms at 3T
PDFF: 1.8%Normal range: <5.6%
cT1T2*PDFFcT1T2*PDFF
®
MKT155 2.0
®
[email protected] | perspectum.com | US: (+1) 972 803 5501 | UK: (+44) 1865 655325
Introducing LiverMultiScan
In a single, non-invasive MRI examination, LiverMultiScan® characterizes liver tissue by providing three key metrics—PDFF, T2* and cT1. These have been shown to correlate with liver fat1,2, iron content3,4,5 and fibro-inflammation6,7 respectively.
Clinicians will receive reports that include these quantitative metrics to support the diagnosis ofliver disorders as inputs forming part of a wider diagnostic process.
LiverMultiScan provides measures that can be used to assess a wide variety of liver disorders
Diagnosis of liver disease relies on a range of pathological features. Currently available tests do not capture all aspects of disease progression. LiverMultiScan enables the comprehensive assessment of the liver parenchyma.
Healthy Liver
Fatty Liver
Inflamed Liver
FibroticLiver
CirrhoticLiver
ULTRASOUND ELASTOGRAPHY
LiverMultiScan provides quantitative metrics for liver tissue characterization
Healthy Patient NASH Patient
cT1: 950msReference range: 633-794ms
T2*: 15.3msNormal range: >12.5ms at 3T
PDFF: 22.5%Normal range: <5.6%
cT1: 645msReference range: 633-794ms
T2*: 18.2msNormal range: >12.5ms at 3T
PDFF: 1.8%Normal range: <5.6%
cT1 T2* PDFF cT1 T2* PDFF
®
MKT155 2.0
®
[email protected] | perspectum.com | US: (+1) 972 803 5501 | UK: (+44) 1865 655325
FAQ’S
How long is the scan and is it longer than a normal MRE or MRI-PDFF? LiverMultiScan includes three measures—PDFF, T2* and cT1. The total acquisition time in the MRI scanner is less than 7 minutes and the entire procedure lasts up to 15 minutes (includes time for patient preparation). LiverMultiScan is not substantially longer than a normal MRE or MRI-PDFF examination which provides information for one measure only.
Can you scan just the liver and not the other parts of the abdomen?The procedure requires the abdomen to be scanned to ensure complete coverage of the liver. Technicians will focus the field of view on the area to be scanned, but some of the tissue surrounding the liver may also be acquired in the scan. Although surrounding tissue will be imaged, metrics will only be quantified from the liver.
Does this add more cost to the patient and will it be approved by insurance?Reimbursement for an abdominal MRI may fall under clinical indications when there is evidence of advanced fibrosis, high-risk features or other clinical indications as determined by insurance providers.
Will this exam be useful for more than just NASH? The exam can be used as a diagnostic aid for the evaluation of many types of liver disorders.References1. Idilman, I.S., et al. (2013). Radiology, 267(3), 767-75. 2. Reeder, C., et al. (2017). Psychol Med, 47(15), 2720-30. 3. Wood, J.C., et al. (2007). Am J Hematol, 82(12), 1132-5. 4. Chandarana, H., et al. (2009). AJR Am J Roentgenol, 193(5), 1550-7. 5. Ganne-Carrie, N., et al. (2000). Gut, 46(2), 277-82. 6. Banerjee, R., et al. (2014). J Hepatol, 60(1), 69-77. 7. Pavlides, M., et al. (2016). J Hepatol, 64(2), 308-15. 8. Chalasani, N., et al. (2018). Hepatology, 67(1), 328-57. 9. Jayaswal, A.N., et al. (2019). DDW, May 18-21, San Diego, 156(6), S-1325. 10. Harrison, S., et al. (2019). EASL, Apr 10-14, Vienna, 70(1), e770.
LiverMultiScan is FDA 510(k) cleared. The metrics reported by LiverMultiScan have undergone extensive verification and validation performance testing; however, use of the device for specific liver disorders has not been evaluated by the US FDA. LiverMultiScan has regulatory clearance in the following territories: US, EU, Hong Kong, Malaysia, Singapore, Australia and New Zealand.
Suspectedpatients
with NASH andadvanced
fibrosis
Elastography for liver stiffness
(undefined cut-off) Lifestyle intervention, follow-up for
monitoring
Liver biopsy
NASH treatment
High-risk Low-risk
Based on current AASLD guidance8With LiverMultiScan7,9,10
Transforming the NASH clinical work-flow
LiverMultiScan can be incorporated into the clinical work-flow as a diagnostic aid for patients with liver disorders or abnormalities. This is achieved through the non-invasive and highly-repeatable assessment of liver tissue.
Suspectedpatients
with NASH and advanced
fibrosis
Lifestyle intervention, follow-up for
monitoring
Low-risk: cT1 < 825 ms
NASH treatment
High-risk: cT1 ≥ 825 ms
®
MKT155 2.0
®
[email protected] | perspectum.com | US: (+1) 972 803 5501 | UK: (+44) 1865 655325
FAQ’S
How long is the scan and is it longer than a normal MRE or MRI-PDFF? LiverMultiScan includes three measures—PDFF, T2* and cT1. The total acquisition time in the MRI scanner is less than 7 minutes and the entire procedure lasts up to 15 minutes (includes time for patient preparation). LiverMultiScan is not substantially longer than a normal MRE or MRI-PDFF examination which provides information for one measure only.
Can you scan just the liver and not the other parts of the abdomen?The procedure requires the abdomen to be scanned to ensure complete coverage of the liver. Technicians will focus the field of view on the area to be scanned, but some of the tissue surrounding the liver may also be acquired in the scan. Although surrounding tissue will be imaged, metrics will only be quantified from the liver.
Does this add more cost to the patient and will it be approved by insurance?Reimbursement for an abdominal MRI may fall under clinical indications when there is evidence of advanced fibrosis, high-risk features or other clinical indications as determined by insurance providers.
Will this exam be useful for more than just NASH? The exam can be used as a diagnostic aid for the evaluation of many types of liver disorders.References1. Idilman, I.S., et al. (2013). Radiology, 267(3), 767-75. 2. Reeder, C., et al. (2017). Psychol Med, 47(15), 2720-30. 3. Wood, J.C., et al. (2007). Am J Hematol, 82(12), 1132-5. 4. Chandarana, H., et al. (2009). AJR Am J Roentgenol, 193(5), 1550-7. 5. Ganne-Carrie, N., et al. (2000). Gut, 46(2), 277-82. 6. Banerjee, R., et al. (2014). J Hepatol, 60(1), 69-77. 7. Pavlides, M., et al. (2016). J Hepatol, 64(2), 308-15. 8. Chalasani, N., et al. (2018). Hepatology, 67(1), 328-57. 9. Jayaswal, A.N., et al. (2019). DDW, May 18-21, San Diego, 156(6), S-1325. 10. Harrison, S., et al. (2019). EASL, Apr 10-14, Vienna, 70(1), e770.
LiverMultiScan is FDA 510(k) cleared. The metrics reported by LiverMultiScan have undergone extensive verification and validation performance testing; however, use of the device for specific liver disorders has not been evaluated by the US FDA. LiverMultiScan has regulatory clearance in the following territories: US, EU, Hong Kong, Malaysia, Singapore, Australia and New Zealand.
Suspectedpatients
with NASH andadvanced
fibrosis
Elastography for liver stiffness
(undefined cut-off)Lifestyle intervention, follow-up for monitoring
Liver biopsy
NASH treatment
High-riskLow-risk
Based on current AASLD guidance8 With LiverMultiScan7,9,10
Transforming the NASH clinical work-flow
LiverMultiScan can be incorporated into the clinical work-flow as a diagnostic aid for patients with liver disorders or abnormalities. This is achieved through the non-invasive and highly-repeatable assessment of liver tissue.
Suspectedpatients
with NASH and advanced
fibrosis
Lifestyle intervention, follow-up for monitoring
Low-risk: cT1 < 825 ms
NASH treatment
High-risk: cT1 ≥ 825 ms
